Evaluation of a Novel Medical Device to Facilitate Gel Instillation During Change of Long-term Urinary Catheters

NCT03289117 | Completed

• 1 other identifier: 2016 02 01 ver 1_1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, open label, controlled, parallel group study to investigate difference between regional standard procedure and a novel modified procedure (using an additional novel device to facilitate gel installation) for changing long-term indwelling urinary catheters.

Conditions

Urinary Catheters; Retention, Urinary; Incontinence, Urinary; Anesthesia, Local

Keywords

Urinary catheterization; Gel installation; Novel medical device; Indwelling urinary catheter; Long-term urinary catheter; Male patients

Outcome Measures

Primary Outcomes (1)

• Treatment duration (min)

  Treatment duration for procedure

  During procedure

Secondary Outcomes (2)

• Patient's perceived pain (NRS scale)

  During intervention

• Number of gel syringes used

  During intervention

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  During intervention

Study Arms (2)

Novel gel installation device procedure

EXPERIMENTAL

Catheter change with novel device. Each subject will undergo catheter change with novel gel instillation device procedure

Device: Novel gel installation device procedure

Standard procedure

ACTIVE COMPARATOR

Catheter change with standard procedure. Each subject will undergo catheter change with standard procedure

Device: Standard procedure

Interventions

Novel gel installation device procedure DEVICE

Catheter change with novel device Each subject will undergo catheter change with novel gel instillation device

Novel gel installation device procedure

Standard procedure DEVICE

Catheter change with standard procedure Each subject will undergo catheter change with standard procedure

Standard procedure

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has an indwelling catheter and a primary diagnosis that justify continued catheter use
• The patient provides informed consent prior to any study specific procedures
• The patient is considered to benefit from participation in the clinical study

You may not qualify if:

• The patient do not consent to participate in the study
• Trauma to urethra or bladder
• Infection to urethra or bladder
• Other diagnosis that contraindicates participation in the clinical study as judged by the responsible physician

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator
• Vinnova: collaborator
• Innovation Skåne AB/ Sweden: collaborator

Study Sites (1)

Skåne University Hospital - Urology clinic - Homecare unit

Lund, 22185, Sweden

Location

MeSH Terms

Conditions

Urinary Retention; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulf Malmqvist, PhD

  Clinical Studies Sweden - Forum South

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Open label
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm 1: Experimental: Novel device: Assigned Interventions: Catheter change with novel device. Each subject will undergo catheter change with novel gel instillation device. Arm 2: Comparator: Standard procedure: Assigned Interventions: Catheter change with standard procedure. Each subject will undergo catheter change with standard procedure.

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 20, 2017
• Study Start: April 17, 2016
• Primary Completion: May 26, 2017
• Study Completion: May 26, 2017
• Last Updated: October 20, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)